MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER LEVEEN¿ COACCESS¿; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	M001262240
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complaint device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).
Event or Problem Description
It was reported that insufficient roll-off occurred.The patient was undergoing a radiofrequency ablation (rfa) treatment.A 4.0/15/15 leveen¿ coaccess¿ electrode was used; however roll-off was unable to be achieved.The right steps were followed and the pads and needles were placed accurately.There were no errors found.When the physician removed the needle from the patient, it was cold and there was no sign of heat.The procedure was not completed.No patient complications were reported and the patient's condition was stable.

• Brand Name: LEVEEN¿ COACCESS¿
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7037522
• Report Number: 2134265-2017-11318
• Device Sequence Number: 13694690
• Product Code: GEI
• UDI-Device Identifier: 08714729454939
• UDI-Public: 08714729454939
• Combination Product (Y/N): N
• PMA/510(K) Number: K012315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/14/2020
• Device Model Number: M001262240
• Device Catalogue Number: 26-224
• Device Lot Number: 20642428
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1